INTERNATIONAL STANDARD ISO 14607 Third edition 2018-04 Corrected version 2018-08 Non-active surgical implants Mammary implants Particular requirements Implants chirurgicaux non actifs Implants mammaires Exigences particulières Reference number ISO 14607:2018(E) ISO 2018
ISO 14607:2018(E) COPYRIGHT PROTECTED DOCUMENT ISO 2018 All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISO s member body in the country of the requester. ISO copyright office CP 401 Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone: +41 22 749 01 11 Fax: +41 22 749 09 47 Email: copyright@iso.org Website: www.iso.org Published in Switzerland ii ISO 2018 All rights reserved
ISO 14607:2018(E) Contents Page Foreword...v Introduction...vii 1 Scope... 1 2 Normative references... 1 3 Terms and definitions... 1 4 Intended performance... 3 5 Design attributes... 3 6 Materials... 3 6.1 General... 3 6.2 Cytotoxicity... 4 6.3 Residual low molecular weight oligomers... 4 6.4 Trace elements... 4 6.5 Physico-mechanical properties and characterization... 4 6.6 Documentation of materials... 4 7 Design evaluation... 5 7.1 General... 5 7.2 Pre-clinical evaluation... 5 7.2.1 General... 5 7.2.2 Mechanical tests... 5 7.2.3 Physical evaluation... 6 7.2.4 Chemical evaluation... 7 7.2.5 Biological evaluation... 7 7.3 Clinical evaluation... 7 7.4 Post-market surveillance... 7 8 Manufacturing... 7 9 Sterilization... 7 10 Packaging... 7 11 Information supplied by the manufacturer... 8 11.1 General... 8 11.2 Product labelling... 8 11.3 Information for the user... 8 11.3.1 General... 8 11.3.2 Resterilization... 8 11.3.3 Effects on diagnostic techniques... 8 11.4 Marking on implants... 8 11.5 Filling materials... 8 11.6 Information on expected lifetime... 8 11.7 Information for the patient... 9 11.7.1 General... 9 11.7.2 Patient record label... 9 11.7.3 Patient card... 9 Annex A (normative) Determination of octamethylcyclotetrasiloxane (D4) and decamethylcyclopentasiloxane (D5) in silicone gels...10 Annex B (normative) Tests for shell integrity...14 Annex C (normative) Mechanical tests on a mammary implant in its implantable state...17 Annex D (normative) Test method for valve competence and injection site competence...23 Annex E (normative) Test for silicone gel cohesion (silicone filling materials only)...25 ISO 2018 All rights reserved iii
ISO 14607:2018(E) Annex F (normative) Test for silicone gel penetration (silicone filling materials only)...27 Annex G (informative) Assessment of silicone diffusion from mammary implants using an in vitro method...32 Annex H (informative) Test for surface characteristics...36 Annex I (normative) Information for the user...39 Annex J (normative) Information for the patient...40 Bibliography...41 iv ISO 2018 All rights reserved
ISO 14607:2018(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives). Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents). Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement. For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO's adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html. This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, This third edition cancels and replaces the second edition (ISO 14607:2007), which has been technically revised. The main changes compared to the previous edition are as follows: limit values for trace elements have been added (6.4); determination of octamethylcyclotetrasiloxane (D4) and decamethylcyclopentasiloxane (D5) in silicone gels (new Annex A) has been included; mechanical test on a mammary implant in its implantable state (new Annex C, previously Annex E), specifically the fatigue test (C.1), has undergone major revision; test for silicone gel penetration (silicone filling materials only) (new Annex F) has been included; silicone diffusion assessment from mammary implants by an in vitro method (new Annex G, previously Annex H) has undergone major revision; test for surface characteristics (new Annex H, previously Annex A) has undergone major revision. ISO 2018 All rights reserved v
ISO 14607:2018(E) This corrected version of ISO 14607:2018 incorporates the following corrections: In B.2.2, second paragraph, "shell adjacent to the bonded area," has been changed to "test specimen", "," after " Figure B.2" has been deleted, and "held" has been changed to "maintained". In B.2.3, first paragraph, "shell adjacent to the bonded area" has been changed to "test specimen designated l 0 in Figure B.1 and Figure B.2" and "held" has been changed to "maintained". prostheses projection has been replaced by anterior projection in two instances, in C.1.6 a) and C.2.5 a). implant projection has been replaced by anterior projection in two instances, in C.2.3 c). In G.2.4, first paragraph, for meeting has been deleted. In G.3.2, third paragraph, 6 Vi ± 0,03Vi has been replaced by 6,00 Vi ± 0,03Vi. vi ISO 2018 All rights reserved
ISO 14607:2018(E) Introduction There are three levels of International Standards dealing with non-active surgical implants. These are as follows (with level 1 being the highest): Level 1: General requirements for non-active surgical implants; Level 2: Particular requirements for families of non-active surgical implants; Level 3: Specific requirements for types of non-active surgical implants. This document is a level 2 standard and contains particular requirements for a family of mammary implants. The level 1 standard, ISO 14630, contains requirements that apply to all non-active surgical implants. It also indicates that there are additional requirements in the level 2 and level 3 standards. To address all requirements, the lowest available level is the level to start with. ISO 2018 All rights reserved vii
INTERNATIONAL STANDARD ISO 14607:2018(E) Non-active surgical implants Mammary implants Particular requirements 1 Scope This document specifies particular requirements for mammary implants. With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, packaging, sterilization, and information supplied by the manufacturer. 2 Normative references The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 34-1:2015, Rubber, vulcanized or thermoplastic Determination of tear strength Part 1: Trouser, angle and crescent test pieces ISO 37:2017, Rubber, vulcanized or thermoplastic Determination of tensile stress-strain properties ISO 4287, Geometrical Product Specifications (GPS) Surface texture: Profile method Terms, definitions and surface texture parameters ISO 7619-1, Rubber, vulcanized or thermoplastic Determination of indentation hardness Part 1: Durometer method (Shore hardness) ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process ISO 10993-5, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity ISO 10993-18, Biological evaluation of medical devices Part 18: Chemical characterization of materials ISO 11607-1, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems ISO 14155, Clinical investigation of medical devices for human subjects Good clinical practice ISO 14630:2012, Non-active surgical implants General requirements ASTM D412 16, Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers Tension ASTM D624 00 (2012), Standard guide for evaluation of thermoplastic polyurethane solids and solutions for biomedical applications ASTM D792 13, Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement ASTM D2240 15, Standard Test Method for Rubber Property Durometer Hardness 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 10993-1, ISO 14155 and ISO 14630 and the following apply. ISO 2018 All rights reserved 1